Unlocking Bespoke Product Approvals: FDA Puts Forth Plausible Mechanism Pathway

On November 12, 2025, the New England Journal of Medicine published an article authored by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad introducing the concept of a “plausible mechanism” pathway to facilitate the development and approval of personalized therapies, in cases where traditional randomized controlled trials are not feasible. This pathway would apply to diseases with a well-defined biological cause and focus on conditions…
By: Katten Muchin Rosenman LLP